Z-1621-2014Class II

InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110...

Name: Z-1621-2014 InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110...
Creator: InterValve Inc
Published: 2014-03-14
License: https://open.fda.gov/license/

Intervalve, Inc. / initiated 2014-03-14 / Terminated / root cause: manufacturing process

FDA source

InterValve Inc began a recall of InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic... on 2014-03-14. FDA classified it as Class II and gives the reason as "Leak issues were discovered through accelerated age testing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1621-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-14
Posted: 2014-05-15
Terminated: 2014-06-16
Recalling firm: Intervalve, Inc.
Product: InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
Product code: OZT Balloon Aortic Valvuloplasty
Reason for recall: Leak issues were discovered through accelerated age testing.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Since this recall involved only 2 units at one site, the devices were picked up by the sales representative. There was no written communication regarding this. The site was verbally informed that there was a problem with the device that manifests itself during prepping and the devices need to be retrieved for retest.
Quantity in commerce: 2
Distribution: Distribution to TN only
Product codes and lots: Lot numbers: 101637, 101640

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1621-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1621-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-15

Product code OZT

K133607Class IIV8 Transluminal Bav CatheterIntervalve, Inc. / cleared 2014-02-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)